Starlight Pro and Siliverlight Dental Curing Lights
FDA 510(k) K092951 · Mectron S.P.A.
510(k) numberK092951
Submission
- Device name
- Starlight Pro and Siliverlight Dental Curing Lights
- Applicant
- Mectron S.P.A.
Carasco, IT - Received
- September 24, 2009
- Decision date
- December 7, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K223142 | Coltolux Comfort LED Curing LightEBZ · Traditional | Dent4you AG | 12/22/2022SE |
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Questions and answers
When was Starlight Pro and Siliverlight Dental Curing Lights cleared by the FDA?
Starlight Pro and Siliverlight Dental Curing Lights (K092951) received a 510(k) decision of Substantially Equivalent on December 7, 2009, 74 days after the submission was received.
What is the product code of K092951?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.